Apparatus and method for remote self-identification of components in medical device systems

ABSTRACT

A system and method for providing automated self-identification information of a remote medical component of an implantable medical device system to a centralized computer is disclosed. The system includes a memory component of the remote medical component containing self-identification information. An information network of the centralized expert data center is globally located relative to the programmer. An interface between the programmer and the information network is established for transmitting the self-identification information from the programmer component to the information network. An information identification module located in the information network recognizes the self-identification information of the components of the programmer.

This application is a continuation of application Ser. No. 09/429,956,filed Oct. 29, 1999.

THE FIELD OF THE INVENTION

The present invention relates generally to medical device systems.Specifically, the invention pertains to a remote bi-directionalcommunications with one or more programmable devices, that areassociated with implantable medical devices. More specifically, theinvention relates to an integrated system and method of bi-directionaltelecommunications between a web-based expert data center and at leastone programmer, utilizing various types of network platforms andarchitecture to implement, in the programmer, distance-basedself-identification of components, troubleshooting, maintenance,upgrade, information and administrative services thereby providing aneconomical and highly interactive system for therapy and clinical care.

BACKGROUND OF THE INVENTION

A technology-based health care system that fully integrates thetechnical and social aspects of patient care and therapy should be ableto flawlessly connect the client with care providers irrespective ofseparation distance or location of the participants. While clinicianswill continue to treat patients in accordance with accepted modernmedical practice, developments in communications technology are makingit ever more possible to provide medical services in a time and placeindependent manner.

Prior art methods of clinical services are generally limited toin-hospital operations. For example, if a physician needs to review theperformance parameters of an implantable device in a patient, it islikely that the patient has to go to the clinic. Further, if the medicalconditions of a patient with an implantable device warrant a continuousmonitoring or adjustment of the device, the patient would have to stayin a hospital indefinitely. Such a continued treatment plan poses botheconomic and social problems. Under the exemplary scenario, as thesegment of the population with implanted medical devices increases manymore hospitals/clinics including service personnel will be needed toprovide in-hospital service for the patients, thus escalating the costof healthcare. Additionally the patients will be unduly restricted andinconvenienced by the need to either stay in the hospital or make veryfrequent visits to a clinic.

Yet another condition of the prior art practice requires that a patientvisit a clinical center for occasional retrieval of data from theimplanted device to assess the operations of the device and gatherpatient history for both clinical and research purposes. Such data isacquired by having the patient in a hospital/clinic to down load thestored data from the implantable medical device. Depending on thefrequency of data collection this procedure may pose a seriousdifficulty and inconvenience for patients who live in rural areas orhave limited mobility. Similarly, in the event a need arises to upgradethe software of an implantable medical device, the patient will berequired to come into the clinic or hospital to have the upgradeinstalled. Further, in medical practice it is an industry-wide standardto keep an accurate record of past and present procedures relating to anIMD. Generally, a report should be generated each time a medicalcomponent such as a programmer and/or analyzer is connected to the IMD.Various information should be contained in the report including anidentification of all the medical components used during a procedure.Specifically, all peripheral and major devices that are used in downlinking to the IMD need to be reported. Presently, there is no automatedsystem for providing an automated report of all the major componentsused in a procedure involving communications with an IMD. The currentpractice is for a medical person to physically record or enter datarelated to the devices used in the down linking procedure. One of thelimitations of this procedure is the fact that it is error prone andoften requires rechecking of the data to verify accuracy. Further, thecurrent method does not lend itself to a centralized network whereidentification and related data for globally distributed programmers andperipheral devices used in conjunction with IMDs, could be stored.

A further limitation of the prior art relates to the management ofmultiple implantable devices in a single patient. Advances in modernpatient therapy and treatment have made it possible to implant a numberof devices in a patient. For example, implantable devices such as adefibrillator or a pacer, a neural implant, a drug pump, a separatephysiologic monitor and various other implantable devices may beimplanted in a single patient. To successfully manage the operations andassess the performance of each device in a patient with multi-implantsrequires a continuous update and monitoring of the devices. Further, itmay be preferred to have an operable communication between the variousimplants to provide a coordinated clinical therapy to the patient. Thus,there is a need to monitor the performance of the implantable devices ona regular, if not a continuous, basis to ensure optimal patient care. Inthe absence of other alternatives, this imposes a great burden on thepatient if a hospital or clinic is the only center where the necessaryfrequent follow up, evaluation and adjustment of the medical devicescould be made. Moreover, even if feasible the situation would requirethe establishment of multiple service areas or clinic centers to provideadequate service to the burgeoning number of multi-implant patientsworldwide. Accordingly, it is vital to have a programmer unit that wouldconnect to a remote expert medical center to provide access to expertsystems and import the expertise to a local environment. This approachwould enable unencumbered access to the IMD or the patient. Further, theproliferation of patients with multi-implant medical devices worldwidehas made it imperative to provide remote services. Thus, frequent use ofprogrammers to communicate with the IMD and to provide various remoteservices, consistent with the disclosure contained in co-pendingapplications titled “Apparatus and Method for Remote Troubleshooting,Maintenance and Upgrade of Implantable Device Systems,” filed on Oct.26, 1999, which is incorporated by reference herein in its entirety, hasbecome an important aspect of patient care.

The prior art provides various types of remote sensing andcommunications with an implanted medical device. One such system is, forexample, disclosed in Funke, U.S. Pat. No. 4,987,897 issued Jan. 29,1991. This patent discloses a system that is at least partiallyimplanted into a living body with a minimum of two implanted devicesinterconnected by a communication transmission channel. The inventionfurther discloses wireless communications between an external medicaldevice/programmer and the implanted devices.

One of the limitations of the system disclosed in the Funke patentincludes the lack of communication between the implanted devices,including the programmer, with a remote clinical station. If, forexample, any assessment, monitoring or maintenance is required to beperformed on the IMD the patient will have to go to the remote clinicstation or the programmer device needs to be brought to the patient'slocation. More significantly, the operational worthiness and integrityof the programmer cannot be evaluated remotely thus making it unreliableover time as it interacts with the IMD.

Yet another example of sensing and communications system with aplurality of interactive implantable devices is disclosed by Stranbergin U.S. Pat. No. 4,886,064, issued Dec. 12, 1989. In this disclosure,body activity sensors, such as temperature, motion, respiration and/orblood oxygen sensors, are positioned in a patient's body outside a pacercapsule. The sensors wirelessly transmit body activity signals, whichare processed by circuitry in the heart pacer. The heart pacingfunctions are influenced by the processed signals. The signaltransmission is a two-way network and allows the sensors to receivecontrol signals for altering the sensor characteristics.

One of the many limitations of Stranberg is the fact that although thereis corporeal two-way communications between the implantable medicaldevices, and the functional response of the heart pacer is processed inthe pacer after collecting input from the other sensors, the processoris not remotely programmable. Specifically, the system does not lenditself to web-based communications to enable remote troubleshooting,maintenance and upgrade from outside the patient's body because theprocessor/programmer is internally located in the patient forming anintegral part of the heart pacer.

Yet another prior art reference provides a multi-module medicationdelivery system as disclosed by Fischell in U.S. Pat. No. 4,494,950issued Jan. 22, 1985. The disclosure relates to a system consisting amultiplicity of separate modules that collectively perform a usefulbiomedical purpose. The modules communicate with each other without theuse of interconnecting wires. All the modules may be installedintracorporeal or mounted extracorporeal to the patient. In thealternate, some modules may be intracorporeal with others beingextracorporeal. Signals are sent from one module to the other byelectromagnetic waves. Physiologic sensor measurements sent from a firstmodule cause a second module to perform some function in a closed loopmanner. One extracorporeal module can provide electrical power to anintracorporeal module to operate a data transfer unit for transferringdata to the external module.

The Fischell disclosure provides modular communication and cooperationbetween various medication delivery systems. However, the disclosuredoes not provide an external programmer with remote sensing, remote datamanagement and maintenance of the modules. Further, the system doesneither teach nor disclose an external programmer for telemetricallyprogramming the modules.

Yet another example of remote monitoring of implanted cardioverterdefibrillators is disclosed by Gessman in U.S. Pat. No. 5,321,618issued. In this disclosure a remote apparatus is adapted to receivecommands from and transmit data to a central monitoring facility overtelephone communication channels. The remote apparatus includesequipment for acquiring a patient's ECG waveform and transmitting thatwaveform to the central facility over the telephone communicationschannels. The remote apparatus also includes a segment, responsive to acommand received from the central monitoring facility, for enabling theemission of audio tone signals from the cardioverter defibrillator. Theaudio tones are detected and sent to the central monitoring facility viathe telephone communication channel. The remote apparatus also includespatient alert devices, which are activated by commands received from thecentral monitoring facility over the telephone communication channel.

One of the many limitations of the apparatus and method disclosed in theGessman patent is the fact that the segment, which may be construed tobe equivalent to a programmer, is not remotely adjustable from thecentral monitoring device. The segment merely acts as a switchingstation between the remote apparatus and the central monitoring station.

An additional example of prior art practice includes a packet-basedtelemedicine system for communicating information between centralmonitoring stations and a remote patient monitoring station disclosed inPeifer, WO 99/14882 published Mar. 25, 1999. The disclosure relates to apacket-based telemedicine system for communicating video, voice andmedical data between a central monitoring station and a patient that isremotely located with respect to the central monitoring station. Thepatient monitoring station obtains digital video, voice and medicalmeasurement data from a patient and encapsulates the data in packets andsends the packets over a network to the central monitoring station.Since the information is encapsulated in packets, the information can besent over multiple types or combination of network architectures,including a community access television (CATV) network, the publicswitched telephone network (PSTN), the integrated services digitalnetwork (ISDN), the Internet, a local area network (LAN), a wide areanetwork (WAN), over a wireless communications network, or overasynchronous transfer mode (ATM) network. A separate transmission codeis not required for each different type of transmission media.

One of the advantages of the Pfeifer invention is that it enables dataof various forms to be formatted in a single packet irrespective of theorigin or medium of transmission. However, the data transfer systemlacks the capability to remotely debug the performance parameters of themedical interface device or the programmer. Further, Pfeifer does notdisclose a method or structure by which the devices at the patientmonitoring station may be remotely updated, maintained and tuned toenhance performance or correct errors and defects.

Another example of a telemetry system for implantable medical devices isdisclosed in Duffin et al, U.S. Pat. No. 5,752,976, issued May 19, 1998,incorporated by reference herein in its entirety. Generally, the Duffinet al disclosure relates to a system and method for communicating with amedical device implanted in an ambulatory patient and for locating thepatient in order to selectively monitor device function from a remotemedical support network. The communications link between the medicalsupport network and the patient communications control device maycomprise a world wide satellite network, a cellular telephone network orother personal communications system.

Although the Duffin et al disclosure provides significant advances overthe prior art, it does not teach a communications scheme in which aprogrammer is remotely debugged, maintained, upgraded or modified toultimately enhance the support it provides to the implantable devicewith which it is associated. Specifically, the Duffin et al disclosureis limited to notifying remote medical support personnel or an operatorabout impending problems with an IMD and also enables constantmonitoring of the patient's position worldwide using the GPS system.However, Duffin et al does not teach the remote programming schemecontemplated by the present invention.

In a related art, Thompson discloses a patient tracking system in acopending application entitled “World-wide Patient Location and DataTelemetry System For Implantable Medical Devices”, Ser. No. 09/045,272,filed on Mar. 20, 1998 which is incorporated by reference herein in itsentirety. The disclosure provides additional features for patienttracking in a mobile environment worldwide via the GPS system. However,the remote programming concepts advanced by the present invention arenot within the purview of the Thompson disclosure because there is noteaching of a web-based environment in which a programmer is remotelyevaluated and monitored to effect functional and parametric tune up,upgrade and maintenance as needed. Further in Thompson, the componentsof the programmer cannot be interrogated for remote identification.

Yet in another related art, Ferek-Petric discloses a system forcommunication with a medical device in a co-pending application, Ser.No. 09/348,506 which is incorporated by reference herein in itsentirety. The disclosure relates to a system that enables remotecommunications with a medical device, such as a programmer.Particularly, the system enables remote communications to inform deviceexperts about programmer status and problems, The experts will thenprovide guidance and support to the remotely to service personnel oroperators located at the programmer. The system may include a medicaldevice adapted to be implanted into a patient; a server PC communicatingwith the medical device; the server PC having means for receiving datatransmitted across a dispersed data communication pathway, such as theInternet; and a client PC having means for receiving data transmittedacross a dispersed communications pathway from the SPC. In certainconfigurations the server PC may have means for transmitting data acrossa dispersed data communication pathway (Internet) along a first channeland a second channel; and the client PC may have means for receivingdata across a dispersed communication pathway from the server PC along afirst channel and a second channel.

One of the significant teachings of Ferek-Petric's disclosure, in thecontext of the present invention, includes the implementation ofcommunication systems, associated with IMDs that are compatible with theInternet. Specifically the disclosure advances the art of remotecommunications between a medical device, such as a programmer, andexperts located at a remote location using the Internet. As indicatedhereinabove, the communications scheme is structured to primarily alertremote experts to existing or impending problems with the programmingdevice so that prudent action, such as early maintenance or otherremedial steps, may be timely exercised. Further, because of the earlywarning or advance knowledge of the problem, the remote expert would bewell informed to provide remote advice or guidance to service personnelor operators at the programmer.

While Ferek-Petric's invention advances the art in communicationssystems relating to interacting with a programmer via a communicationmedium such as the Internet, the system does neither propose nor suggestremote programming, debugging and maintenance of a programmer withoutthe intervention of a service person. Further, Ferek-Petric's disclosuredoes not disclose a remote interrogation scheme to identify componentsused in a programmer-IMD interaction procedure.

Accordingly it would be advantageous to provide a system in which aprogrammer could uplink to a remote expert data center to importenabling software for self-diagnosis, maintenance and upgrade of theprogrammer. Yet another desirable advantage would be to provide a systemto implement the use of remote expert systems to manage a programmer ona real-time basis. A further desirable advantage would be to provide acommunications scheme that is compatible with various communicationsmedia, to promote a fast uplink of a programmer to remote expert systemsand specialized data resources. Yet another desirable advantage would beto provide a high speed communications scheme to enable the transmissionof high fidelity sound, video and data to advance and implementefficient remote data management, including self-identification ofcomponents in medical device system, to provide a clinical/therapysystem that would enhance patient clinical care. As discussed hereinbelow, the present invention provides these and other desirableadvantages.

SUMMARY OF THE INVENTION

The present invention generally relates to a communications scheme inwhich a remote web-based expert data center interacts with a patienthaving one or more implantable medical devices (IMDs) via an associatedexternal medical device, preferably a programmer, located in closeproximity to the IMDs. Some of the most significant advantages of theinvention include the use of various communications media between theremote web-based expert data center and the programmer to remotelyexchange clinically significant information including identification ofspecific components of the programmer.

In the context of the present invention, one of the many aspects of theinvention includes a real-time access of a programmer to a remoteweb-based expert data center, via a communication network, whichincludes the Internet. The operative structure of the invention includesthe remote web-based expert data center, in which an expert system ismaintained, having a bi-directional real-time data, sound and videocommunications with the programmer via a broad range of communicationlink systems. The programmer is in turn in telemetric communicationswith the IMDs such that the IMDs may uplink to the programmer or theprogrammer may down link to the IMDs, as needed.

In yet another context of the invention, the critical components andembedded systems of the programmer are remotely identified, maintained,debugged and/or evaluated to ensure proper functionality and performanceby down linking expert systems and compatible software from theweb-based expert data center.

In a further context of the invention, a programmer is remotelyidentified monitored, assessed and upgraded as needed by importingexpert systems from a remote expert data center via a wireless orequivalent communications system. The operational and functionalsoftware of the embedded systems in the programmer may be remotelyadjusted, upgraded or changed as apparent. Some of the software changesmay ultimately be implemented in the IMDs as needed by down linking fromthe programmer to the IMDs. Further, specific components used inprogrammer-IMD interface will be identified and documented to complywith medical standards.

Yet another context of the invention includes a communications schemethat provides a highly integrated and efficient method and structure ofclinical information management in which various networks such asCommunity access Television, Local area Network (LAN), a wide areanetwork (WAN) Integrated Services Digital Network (ISDN), the PublicSwitched telephone Network (PSTN), the Internet, a wireless network, anasynchronous transfer mode (ATM) network, a laser wave network,satellite, mobile and other similar networks are implemented to transfervoice, data and video between the remote data center and a programmer.In the preferred embodiment, wireless communications systems, a modemand laser wave systems are illustrated as examples only and should beviewed without limiting the invention to these types of communicationsalone. Further, in the interest of simplicity, the applicants refer tothe various communications system, in relevant parts, as a communicationsystems. However, it should be noted that the communication systems, inthe context of this invention, are interchangeable and may relate tovarious schemes of cable, fiber optics, microwave, radio, laser andsimilar communications or any practical combinations thereof.

Some of the distinguishing features of the present invention include theuse of a robust web-based expert data center to manage theprogrammer-IMD events and identify the programmer components usedtherein and tune the operational and functional parameters of aprogrammer in real-time. Specifically, the invention enables remotediagnosis, maintenance, upgrade, performance tracking, tuning andadjustment of a programmer from a remote location. Although the presentinvention focuses on the remote real-time monitoring and management ofthe programmer, some of the changes and upgrades made to the programmercould advantageously be transferred to the IMDs. This is partly becausesome of the performance parameters of the programmer are functionallyparallel to those in the IMDs. Thus, one additional benefit of thepresent invention is an enhancement of the programmer may beimplemented, on a proactive basis, in the IMDs by down linking from theprogrammer thereby upgrading the IMDs to promote the patient's wellbeing.

Yet one of the other distinguishing features of the invention includesthe use a highly flexible and adaptable communications scheme to promotecontinuous and real-time communications between a remote expert datacenter and a programmer associated with a plurality of IMDs. The IMDsare structured to share information intracorporeally and may interactwith the programmer, as a unit. Specifically, the IMDs either jointly orseverally can be interrogated to implement or extract clinicalinformation as required. In other words, all of the IMDs may be accessedvia one IMD or, in the alternate, each one of the IMDs may be accessedindividually. The information collected in this manner may betransferred to the programmer by up linking the IMDs as needed.

Further, the present invention provides significant advantages over theprior art by enabling remote automated self-identification informationof a programmer. The automated self-identification scheme is compatiblewith a global preferably web-based data center which is configured tointerrogate and obtain the identification of components. Primarily, thecomponent-identification procedure relates to the programmer-IMDsessions. Components used in these sessions are identified and centrallylogged for reference and compliance requirements. Generally, theweb-based expert data center will interrogate the programmer to identifycomponents used in the sessions.

The invention provides significant compatibility and scalability toother web-based applications such as telemedicine and emerging web-basedtechnologies such as tele-immersion. For example, the system may beadapted to webtop applications in which a webtop unit may be used touplink the patient to a remote data center for non-critical informationexchange between the IMDs and the remote expert data center. In theseand other web-based similar applications the data collected, in themanner and substance of the present invention, may be used as apreliminary screening to identify the need for further interventionusing the advanced web technologies.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be appreciated as the same becomes betterunderstood by reference to the following detailed description of thepreferred embodiment of the invention when considered in connection withthe accompanying drawings, in which like numbered reference numbersdesignate like parts throughout the figures thereof, and wherein:

FIG. 1 is a simplified schematic diagram of major uplink and downlinktelemetry communications between a remote clinical station, a programmerand a plurality of implantable medical devices (IMDs);

FIG. 2 is a block diagram representing the major components of an IMD;

FIG. 3A is a block diagram presenting the major components of aprogrammer or webtop unit;

FIG. 3B is a block diagram representing a laser transceiver for highspeed transmission of voice, video and other data;

FIG. 4 is a block diagram illustrating the organizational structure ofthe wireless communication system in accordance with the presentinvention;

FIG. 5 is a block diagram illustrating further component details of thestructure depicted in FIG. 4;

FIG. 6 represents a block diagram of identification data sets ofcomponents in a programmer or equivalent medical device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a simplified schematic of the major components of the presentinvention. Specifically, a bi-directional wireless communications systembetween programmer 20, webtop unit 20′ and a number of implantablemedical devices (IMDS) represented by IMD 10, IMD 10′ and IMD 10″ isshown. The IMDs are implanted in patient 12 beneath the skin or muscle.The IMDs are electrically coupled to electrodes 18, 30, and 36respectively in a manner known in the art. IMD 10 contains amicroprocessor for timing, sensing and pacing functions consistent withpreset programmed functions. Similarly, IMDs 10′ and 10″ aremicroprocessor-based to provide timing and sensing functions to executethe clinical functions for which they are employed. For example, IMD 10′could provide neural stimulation to the brain via electrode 30 and IMD10″ may function as a drug delivery system that is controlled byelectrode 36. The various functions of the IMDs are coordinated usingwireless telemetry. Wireless links 42, 44 and 46 jointly and severallycouple IMDs 10, 10′ and 10″ such that programmer 20 may transmitcommands or data to any or all the of IMDs via one of telemetry antennas28, 32 and 38. This structure provides a highly flexible and economicalwireless communications system between the IMDS. Further, the structureprovides a redundant communications system, which enables access to anyone of a multiplicity of IMDs in the event of a malfunction of one ortwo of antennas 28, 32 and 38.

Programming commands or data are transmitted from programmer 20 to IMDs10, 10′ and 10″ via external RF telemetry antenna 24. Telemetry antenna24 may be an RF head or equivalent. Antenna 24 may be located onprogrammer 20 externally on the case or housing. Telemetry antenna 24 isgenerally telescoping and may be adjustable on the case of programmer20. Both programmer 20 and webtop unit 20′ may be placed a few feet awayfrom patient 12 and would still be within range to wirelesslycommunicate with telemetry antennas 28, 32 and 38.

The uplink to remote web-based expert data center 62, hereinafterreferred to as, interchangeably, “data center 62”, “expert data center62 ” or “web-based data center 62” without limitations, is accomplishedthrough programmer 20 or webtop unit 20′. Accordingly programmer 20 andwebtop unit 20′ function as an interface between IMDs 10, 10′ and 10″and data center 62. One of the many distinguishing elements of thepresent invention includes the use of various scalable, reliable andhigh-speed wireless communication systems to bi-directionally transmithigh fidelity digital/analog data between programmer 20 and data center62.

There are a variety of wireless mediums through which datacommunications could be established between programmer 20 or webtop unit20′ and data center 62. The communications link between Programmer 20 orwebtop unit 20′ and data center 62 could be modem 60, which is connectedto programmer 20 on one side at line 63 and data center 62 at line 64 onthe other side. In this case, data is transferred from data center 62 toprogrammer 20 via modem 60. Alternate data transmission systems include,without limitations, stationary microwave and/or RF antennas 48 beingwirelessly connected to programmer 20 via tunable frequency wavedelineated by line 50. Antenna 48 is in communications with data center62 via wireless link 65. Similarly, webtop unit 20′, mobile vehicle 52and satellite 56 are in communications with data center 62 via wirelesslink 65. Further, mobile system 52 and satellite 56 are in wirelesscommunications with programmer 20 or webtop unit 20′ via tunablefrequency waves 54 and 58, respectively.

In the preferred embodiment a Telnet system is used to wirelessly accessdata center 62. Telnet emulates a client/server model and requires thatthe client run a dedicated software to access data center 62. The Telnetscheme envisioned for use with the present invention includes variousoperating systems including UNIX, Macintosh, and all versions ofWindows.

Functionally, an operator at programmer 20 or an operator at data center62 would initiate remote contact. Programmer 20 is down linkable to IMDsvia link antennas 28, 32 and 38 to enable data reception andtransmission. For example, an operator or a clinician at data center 62may downlink to programmer 20 to perform a routine or a scheduledevaluation of programmer 20. In this case the wireless communication ismade via wireless link 65. If a downlink is required from programmer 20to IMD 10 for example, the downlink is effected using telemetry antenna22. In the alternate, if an uplink is initiated from patient 12 toprogrammer 20 the uplink is executed via wireless link 26. As discussedherein below, each antenna from the IMDs can be used to uplink all orone of the IMDs to programmer 20. For example, IMD 10″ which relates toneural implant 30 can be implemented to up-link, via wireless antenna 34or wireless antenna 34′, any one, two or more IMDs to programmer 20.Preferably bluetooth chips, adopted to function within the body tooutside the body and also adopted to provide low current drain, areembedded in order to provide wireless and seamless connections 42, 44and 46 between IMDs 10, 10′ and 10″. The communication scheme isdesigned to be broadband compatible and capable of simultaneouslysupporting multiple information sets and architecture, transmitting atrelatively high speed, to provide data, sound and video services ondemand.

FIG. 2 illustrates typical components of an IMD, such as thosecontemplated by the present invention. Specifically, major operativestructures common to all IMDs 10, 10′ and 10″ are represented in ageneric format. In the interest of brevity, IMD 10 relative to FIG. 2refers to all the other IMDs. Accordingly, IMD 10 is implanted inpatient 12 beneath the patient's skin or muscle and is electricallycoupled to heart 16 of patient 12 through pace/sense electrodes and leadconductor(s) of at least one cardiac pacing lead 18 in a manner known inthe art. IMD 10 contains timing control 72 including operating systemthat may employ microprocessor 74 or a digital state machine for timing,sensing and pacing functions in accordance with a programmed operatingmode. IMD 10 also contains sense amplifiers for detecting cardiacsignals, patient activity sensors or other physiologic sensors forsensing the need for cardiac output, and pulse generating outputcircuits for delivering pacing pulses to at least one heart chamber ofheart 16 under control of the operating system in a manner well known inthe prior art. The operating system includes memory registers or RAM/RQM76 for storing a variety of programmed-in operating mode and parametervalues that are used by the operating system. The memory registers orRAM/ROM 76 may also be used for storing data compiled from sensedcardiac activity and/or relating to device operating history or sensedphysiologic parameters for telemetry out on receipt of a retrieval orinterrogation instruction. All of these functions and operations arewell known in the art, and many are generally employed to storeoperating commands and data for controlling device operation and forlater retrieval to diagnose device function or patient condition.

Programming commands or data are transmitted between IMD 10 RF telemetryantenna 28, for example, and an external RF telemetry antenna 24associated with programmer 20. In this case, it is not necessary thatthe external RF telemetry antenna 24 be contained in a programmer RFhead so that it can be located close to the patient's skin overlyingIMD10. Instead, the external RF telemetry antenna 24 can be located onthe case of programmer 20. It should be noted that programmer 20 can belocated some distance away from patient 12 and is locally placedproximate to the IMDs such that the communication between IMDs 10, 10′and 10″ and programmer 20 is telemetric. For example, programmer 20 andexternal RF telemetry antenna 24 may be on a stand a few meters or soaway from patient 12. Moreover, patient 12 may be active and could beexercising on a treadmill or the like during an uplink telemetryinterrogation of real time ECG or other physiologic parameters.Programmer 20 may also be designed to universally program existing IMDsthat employ RF telemetry antennas of the prior art and therefore alsohave a conventional programmer RF head and associated software forselective use therewith.

In an uplink communication between IMD 10 and programmer 20, forexample, telemetry transmission 22 is activated to operate as atransmitter and external RF telemetry antenna 24 operates as a telemetryreceiver. In this manner data and information may be transmitted fromIMD10 to programmer 20. In the alternate, IMD 10 RF telemetry antenna 26operates as a telemetry receiver antenna to downlink data andinformation from programmer 20. Both RF telemetry antennas 22 and 26 arecoupled to a transceiver comprising a transmitter and a receiver.

FIG. 3A is a simplified circuit block diagram of major functionalcomponents of programmer 20. The external RF telemetry antenna 24 onprogrammer 20 is coupled to a telemetry transceiver 86 and antennadriver circuit board including a telemetry transmitter and telemetryreceiver 34. The telemetry transmitter and telemetry receiver arecoupled to control circuitry and registers operated under the control ofmicrocomputer 80. Similarly, within IMD 10, for example, the RFtelemetry antenna 26 is coupled to a telemetry transceiver comprising atelemetry transmitter and telemetry receiver. The telemetry transmitterand telemetry receiver in IMD 10 are coupled to control circuitry andregisters operated under the control of microcomputer 74.

Further referring to FIG. 3A, programmer 20 is a personal computer type,microprocessor-based device incorporating a central processing unit,which may be, for example, an Intel Pentium microprocessor or the like.A system bus interconnects CPU 80 with a hard disk drive, storingoperational programs and data, and with a graphics circuit and aninterface controller module. A floppy disk drive or a CD ROM drive isalso coupled to the bus and is accessible via a disk insertion slotwithin the housing of programmer 20. Programmer 20 further comprises aninterface module, which includes a digital circuit, a non-isolatedanalog circuit, and an isolated analog circuit. The digital circuitenables the interface module to communicate with interface controllermodule. Operation of the programmer in accordance with the presentinvention is controlled by microprocessor 80.

In order for the physician or other caregiver or operator to communicatewith the programmer 20, a keyboard or input 82 coupled to CPU 80 isoptionally provided. However the primary communications mode may bethrough graphics display screen of the well-known “touch sensitive” typecontrolled by a graphics circuit. A user of programmer 20 may interacttherewith through the use of a stylus, also coupled to a graphicscircuit, which is used to point to various locations on screen ordisplay 84 which display menu choices for selection by the user or analphanumeric keyboard for entering text or numbers and other symbols.Various touch-screen assemblies are known and commercially available.Display 84 and or the keyboard comprise means for entering commandsignals from the operator to initiate transmissions of downlink oruplink telemetry and to initiate and control telemetry sessions once atelemetry link with data center 62 or an implanted device has beenestablished. Display screen 84 is also used to display patient relateddata and menu choices and data entry fields used in entering the data inaccordance with the present invention as described below. Display screen84 also displays a variety of screens of telemetered out data or realtime data. Display screen 84 may also display plinked event signals asthey are received and thereby serve as a means for enabling the operatorto timely review link-history and status.

Programmer 20 further comprises an interface module, which includesdigital circuit, non-isolated analog circuit, and isolated analogcircuit. The digital circuit enables the interface module to communicatewith the interface controller module. As indicated hereinabove, theoperation of programmer 20, in accordance with the present invention, iscontrolled by microprocessor 80. Programmer 20 is preferably of the typethat is disclosed in U.S. Pat. No. 5,345,362 to Winkler, which isincorporated by reference herein in its entirety.

Screen 84 may also display up-linked event signals when received andthereby serve as a means for enabling the operator of programmer 20 tocorrelate the receipt of uplink telemetry from an implanted device withthe application of a response-provoking action to the patient's body asneeded. Programmer 20 is also provided with a strip chart printer or thelike coupled to interface controller module so that a hard copy of apatient's ECG, EGM, marker channel of graphics displayed on the displayscreen can be generated.

As will be appreciated by those of ordinary skill in the art, it isoften desirable to provide a means for programmer 20 to adapt its modeof operation depending upon the type or generation of implanted medicaldevice to be programmed and to be compliant with the wirelesscommunications system through which data and information is transmittedbetween programmer 20 and data center 62.

FIG. 3B is an illustration of the major components of Wave unit 90utilizing laser technologies such as for example the WaveStar Optic AirUnit, manufactured by Lucent Technologies or equivalent. This embodimentmay be implemented for large data transfer at high speed in applicationsinvolving several programmers. The unit includes laser 92, transceiver94 and amplifier 96. A first wave unit 90 is installed at data center 62and a second unit 90′ is located proximate to programmer 20 or webtopunit 20′. Data transmission between remote data center 62 and programmerunit 20 is executed via wave units 90. Typically, the first wave unit 90accepts data and splits it into unique wavelength for transmission. Thesecond wave unit 90′ recomposes the data back to its original form.

FIG. 4 is a simplified block diagram illustrating the principal systemsof the invention. The Remote expert system or data center 62 includesdata resource 100. As discussed hereinabove, data center 62 ispreferably in wireless communications with programmer 20. The medium ofcommunications between programmer 20 and data center 62 may be selectedfrom one or a combination of several cable and wireless systemsdiscussed hereinabove. Further, programmer 20 is in wirelesscommunications with a number of IMDs, such as shown in FIG. 1. Althoughthree IMDs are shown for illustrative purposes, it should be noted thatseveral IMDs may be implemented and the practice of the presentinvention does not limit the number of implants per se.

FIG. 5 is a representation of the major functional components ofProgrammer 20, data resources 100 and the wireless data communications131 and 136. Specifically, as discussed hereinabove, programmer 20dispersed in local devices 140 includes power supply 110, disc drive112, display screen 114, CD ROM 116, printer 118, RAM/ROM 120 and stylus122. Analyzer 144 is in bidirectional data communications with the othercomponents of programmer 20.

Programmer 20 is connected to remote data center 62 via bidirectionaldata communication link 136. Data resource center forms the web-baseddata resources/expert system 100. Accordingly, data resources system 100is a sub-component of remote data center 62, which includes informationidentification module 152, data storage module 154 and software updatemodule 156.

Referring to programmer 20 in more detail, when a physician or anoperator needs to interact with programmer 20, a keyboard coupled toProcessor 80 is optionally employed. However the primary communicationmode may be through graphics display screen of the well-known “touchsensitive” type controlled by graphics circuit. A user of programmer 20may interact therewith through the use of a stylus 122, also coupled toa graphics circuit, which is used to point to various locations onscreen/display 114 to display menu choices for selection by the user oran alphanumeric keyboard for entering text or numbers and other symbolsas shown in the above-incorporated '362 patent. Various touch-screenassemblies are known and commercially available. The display and or thekeyboard of programmer 20, preferably include means for entering commandsignals from the operator to initiate transmissions of downlinktelemetry from IMDs and to initiate and control telemetry sessions oncea telemetry link with one or more IMDs has been established. Thegraphics display screen 114 is also used to display patient related dataand menu choices and data entry fields used in entering the data inaccordance with the present invention as described below. Graphicsdisplay/screen 114 also displays a variety of screens of telemetered outdata or real time data. Programmer 20 is also provided with a stripchart printer 118 or the like coupled to interface controller module sothat a hard copy of a patient's ECG, EGM, marker channel or similargraphics display can be generated. Further, Programmer 20's historyrelating to instrumentation and software status may be printed fromprinter 118. Similarly, once an uplink is established between programmer20 and any one of IMDs 10, 10′and 10″, various patient history data andIMD performance data may be printed out. The IMDs contemplated by thepresent invention include a cardiac pacemaker, a defibrillator, apacer-defibrillator, implantable monitor (Reveal), cardiac assistdevice, and similar implantable devices for cardiac rhythm and therapy.Further the IMD units contemplated by the present invention includeelectrical stimulators such as, but not limited to, a drug deliverysystem, a neural stimulator, a neural implant, a nerve or musclestimulator or any other implant designed to provide physiologicassistance or clinical therapy.

Data resources 100 represents a high speed computer network system whichis located in remote expert data center 62 having wirelessbi-directional data, voice and video communications with programmer 20via wireless communications link 136. Generally data resources 100 arepreferably located in a central location and are equipped withhigh-speed web-based computer networks. Preferably, the data resourcecenter is manned 24-hours by operators and clinical personnel who aretrained to provide a web-based remote service to programmer 20.Additionally, as discussed hereinabove, data resources 100 provideremote monitoring, maintenance and upgrade of programmer 20. Thelocation of remote data center 62 and, consequently, the location ofdata resources 100 are dependent upon the sphere of service. Inaccordance with the present invention, data resource 100 may be locatedin a corporate headquarters or manufacturing plant of the company thatmanufactures programmer 20. Wireless data communications link/connection136 can be one of a variety of links or interfaces, such as a local areanetwork (LAN), an internet connection, a telephone line connection, asatellite connection, a global positioning system (GPS) connection, acellular connection, a laser wave generator system, any combinationthereof, or equivalent data communications links.

As stated hereinabove, bi-directional wireless communications 136 actsas a direct conduit for information exchange between remote data center62 and programmer 20. Further, bi-directional wireless communications136 provides an indirect link between remote data center and IMDs 10,10′ and 10″ via programmer 20. In the context of this disclosure theword “data” when used in conjunction with bi-directional wirelesscommunications also refers to sound, video and information transferbetween the various centers.

FIG. 6 is a block diagram illustrating programmer 20. It should be notedthat, programmer 20 represents any remote medical component used inconjunction with the IMDs which includes a memory device. The memorydevice can be a microprocessor, a read-only memory (ROM) component, orany other memory component. Programmer 20 may, in the context of thepresent invention, represent IMDs, analyzer 144, or any other remotemedical component having a memory device, such as pacing and/or sensingleads 16 and 18, or a radio frequency (RF) head used to transmitinformation between IMD 10 and programmer 20.

Programmer 20 includes memory component 80 which is a microprocessor, aROM device, or any other component capable of storing information.During a manufacturing procedure, various information identifyingprogrammer 20 is programmed into memory component 80. Memory component80 stores the various information which specifically identifiesprogrammer 20. For example, memory component 80 maintains bar codeinformation 160, serial number 162, model number 164, lot number 166,and manufacture date 168; each of which provides specific identifyinginformation about programmer 20. Other similar identificationinformation can be maintained in memory component 80. Therefore, byretrieving information from within memory component 80, remoteprogrammer 20 can be specifically identified.

Web-based expert data center is a computerized network system locatedremotely to connect with globally distributed programmer 20. Forexample, web-based expert data center can be located at a centrallocation, such as a corporate headquarters or manufacturing plant of thecompany which manufactures and owns programmer 20. Remote medicalinstrument system 252 is connected to remote expert data center 254 viadata communications link/connection 65. Data communicationslink/connection 65 can be one of a variety of links or interfaces, suchas a local area network (LAN) connection, an internet connection, atelephone line connection, a satellite connection, a global positioningsystem connection (GPS), a cellular connection, any combination thereofor equivalent data communications links.

Data communications link/connection 65 permits the exchange of data andinformation between programmer 20 and remote expert data center 62. Asis discussed below, this novel feature of the invention provides one ofthe many distinguishing advantages over the prior art.

Over the last several years, implantable medical devices, such as IMD 10have been implanted in patients throughout the world. Thus, there is abroad world-wide distribution of medical components used in conjunctionwith IMD 10. Accordingly, programmer 20, analyzer 144, and otherperipheral medical components are distributed globally to variousmedical facilities, such as hospitals, clinics, or physician's offices.

Programmer 20 is a microprocessor-based medical component which mayinclude analyzer 144. In the alternative′ analyzer 144 can be a separatestand-alone medical component. Programmer 20 is capable of performingmultiple functions, including (a) assessing lead performance during animplantation procedure, (b) programming the implantable medical device,(c) receiving feed-back information from the implantable medical devicefor use by the operator, and (d) other various analyzation functions.Analyzer 144 is designed to assess the electrical performance of apacing/sensing lead system used in conjunction with an implantablemedical device system. Analyzer 144 utilizes programmed 20 as a controland display platform. If analyzer 144 is a separate medical componentfrom programmer 20, it can be interconnected to programmer 20 via datacommunications link/connection 142. Analyzer 144 is also amicroprocessor-based medical component.

RF head 131 (See FIG. 4), which is also a microprocessor-based medicalcomponent, interconnects to programmer 20 IMDs. RF head 131 is aninterface to transfer information between programmer 20 and IMD 10. Aspreviously discussed, IMD 10 can be one of various devices, such as acardiac pacemaker, a defibrillator, or a pacemaker/defibrillatorcombination. Further, IMD 10 can also be a drug-delivery system, anelectrical stimulator including a nerve or muscle stimulator, aneuro-stimulator, or a heart-assist device or pump. IMD 10 is also amicroprocessor-based medical device.

In a thick data transfer environment, such as the data transfer andcommunication scheme of the present invention, it is both desirable andadvantageous for various components of programmer 20 to includeself-identification information such that remote expert data center 62can retrieve this information. For example, if programmer 20 is dialinginto or interfacing with remote expert data center via datacommunications link/connection 256, it is desirous and advantageous forremote expert data center to identify the specific components of remoteprogrammer 20.

In prior art systems, component identifying information is notautomatically accessible to a centralized computer system. Therefore, acentralized computer system can not automatically identify and recognizeindividual components of a remote medical instrument system. Rather, anoperator, such as a clinician or physician located at the site of theremote medical instrument system, must physically call into acentralized location via a telephone and interact with a person or anautomated system at the centralized location. The operator must provideidentification information for each component of the remote medicalinstrument system such as a serial number, a model number, and/or otheridentifying characteristics for each individual component. The person orautomated process located at the central location must then access thecentralized computer system and enter the identifying information sothat the centralized computer system will recognize the remote medicalsystem.

With the present invention, several components of programmer 20, IMDsand peripheral products could be identified and inventoried for use andmedical record documentation. During the manufacture process of aparticular component, identification information, such as bar codeinformation 160, serial number 162, model number 164, lot number 166,and manufacture date 168 are programmed into memory component 232 of theparticular instrument. During an interface between programmer 20 andremote expert data center, identifying information for each programmeris directly transmitted to information network in remote expert datacenter, and more specifically to information identification module 152of via data communications link/connection 136. Informationidentification module 152 is capable of recognizing the identificationinformation of the components of programmer 20. Therefore, informationidentification module 152 identifies the make, model, memorycapabilities, and hardware configuration of each recognized remotemedical component. With this information, remote expert data center canprovide the necessary assistance to programmer 20. Remote expert datacenter 62 recognizes the specific system with which it is interacting,including the specific remote medical components of programmer 20.Therefore, a completely automated system is accomplished which permitsremote expert data center 62 to identify all various components ofprogrammer 20.

Further, a complete medical history of programmer 20 is maintained atdata storage module 154. The medical history stored in data storagemodule 154 includes the identification of each programmer 20 component.It is critical for remote expert data center to identify programmer 20so that proper communication is established between remote expert datacenter 62 and programmer 20. In addition, programmer 20 may beidentified by the previously discussed identifying information as acomponent having a present or future malfunction tendency. In this case,remote expert data center 62 can identify the programmer and notify anoperator using the alert systems in programmer 20.

In addition, updated software from update software module 156 can betransmitted to and installed into various components of programmer 20via data communications link/connection 136. For example, regardless ofthe purpose for which programmer 20 is connected to remote expert datacenter 62, data resources 100 will automatically review the hardwareconfiguration and software applications of programmer 20 afteridentification. Based upon user performance, an updated softwareapplication approved for installation, will be implemented in programmer20 automatically. In some cases, the software installation is a bytelevel update to software already residing in programmer 20. In othercases, the software installation is a new application replacing anoutdated application. Data identifying the software installation is thentransmitted to data storage module 154.

The invention provides remote self-identification of medical componentsused in conjunction with an implantable medical device system. Theinvention also provides an interface between a remote medical devicesystem and a centralized computer system. Further, the inventionprovides identification information of various components of the remotemedical instrument system which are recognizable by the centralizedcomputer system. Thus, the centralized computer system can automaticallymaintain a complete history of the remote medical instrument system andtransmit and install updated software applications in the remote medicalcomponent.

Although specific embodiments of the invention have been set forthherein in some detail, it is understood that this has been done for thepurposes of illustration only and is not to be taken as a limitation onthe scope of the invention as defined in the appended claims. It is tobe understood that various alterations, substitutions, and modificationsmay be made to the embodiment described herein without departing fromthe spirit and scope of the appended claims.

What is claimed is:
 1. A system for use with an implantable medicaldevice, comprising: a programmer for programming an implantable medicaldevice, said programmer comprising hardware components and a softwarecontent that establish operational and functional parameters of theprogrammer and said programmer further comprising a memory storingidentification information characterizing the software content andhardware components configuration of the programmer; an expert datacenter located remotely from the programmer, comprising: an informationidentification module for recognizing the characterizing identificationinformation stored in the programmer memory; an update software modulecomprising updated programmer software for reviewing and updating thesoftware content in the programmer; and a data storage module forstoring information related to the hardware components that establishthe operational and functional parameters of the programmer; and aninterface linking the programmer and the expert data center inbi-directional communication, said programmer characterizingidentification information and said updated programmer software beingtransferred via said interface.
 2. The system of claim 1 wherein theinterface provides a link between the programmer and the expert datacenter over an Internet connection.
 3. The system of claim 1 wherein theinterface provides a link between the programmer and the expert datacenter over a wireless connection.